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Could an online Brain-Gut therapy ease chronic stomach pain?

NCT ID NCT07636122

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an internet-based cognitive behavioral therapy (iCBT) program is feasible and helpful for adults with functional gastrointestinal disorders (FGID), like irritable bowel syndrome (IBS). Thirty participants will complete a 10-week online program with therapist support, learning to manage symptoms through exposure exercises and behavior changes. The goal is to see if this approach is acceptable and reduces symptom severity and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Internet-delivered cognitive behavioral therapy (iCBT)
What this could lead to
If it works, this could provide a convenient, accessible psychological treatment option for people with functional gut disorders, reducing symptoms and improving quality of life.
What could go wrong
This is a very small feasibility study with only 30 participants and no comparison group. It's too early to know if the treatment is effective, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18. 2. A primary diagnosis of functional disorders, gastrointestinal, specifically irritable bowel syndrome operationalized by ROME IV (DR58) 3. Normal recommended routine medical investigations: growth, blood samples including TSH, total IgA, IgA-tissue transglutaminase, complete blood count, erythrocyte sedimentation rate and C-reactive protein analysis, liver enzymes and fecal calprotectin. 4. Refractory gastrointestinal functional symptoms despite medical treatment (in accordance with guidelines) 5. Stable dosage of FGID-related medication such as laxatives, Imodium or pain-modulating psychopharmacological medication during the past month. 6. Living in Denmark. 7. Access to a computer or tablet with an internet connection. \- Exclusion Criteria: 1. \- Another disease that explains the symptoms. 2. Chronic inflammatory bowel disease (e.g., Crohns, colitis ulcerosa). 3. Lactose intolerance, celiac disease, and food allergies, in accordance with guidelines. 4. Severe psychiatric problems (e.g., suicidal ideation, depression). 5. Insufficient language or computer skills. 6. Addiction to alcohol, drugs or medicine. 7. Treatment with opioids or other addictive drugs such as benzodiazepines 8. Lactose-/gluten-intolerance where the diet has not been adjusted accordingly. 9. Severe cognitive or intellectual dysfunction or diagnosed autism spectrum disorder, which prevent the participant from interaction with the program 10. Ongoing psychological treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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More trials for these conditions

Other studies related to the condition(s) this trial covers.